Maxxi Snore Sensor

Ventilatory Effort Recorder

Neurovirtual USA, INC.

The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxi Snore Sensor.

Pre-market Notification Details

Device IDK191095
510k NumberK191095
Device Name:Maxxi Snore Sensor
ClassificationVentilatory Effort Recorder
Applicant Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale,  FL  33309
ContactEduardo Faria
CorrespondentEduardo Faria
Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale,  FL  33309
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-25
Decision Date2020-01-16

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